C Vignali

Doxorubicin-eluting bead-enhanced radiofrequency ablation of hepatocellular carcinoma: a pilot clinical study

BACKGROUND/AIMS Experimental studies have shown synergy between radiofrequency (RF) ablation and adjuvant chemotherapy in animal tumour models. We aimed to assess safety and efficacy of doxorubicin-eluting bead (DEB)-enhanced RF ablation in the treatment of human hepatocellular carcinoma (HCC). METHODS Twenty patients with single HCC ranging 3.3-7.0 cm (mean, 5.0 cm+/-1.4) showing evidence of residual viable tumour after standard RF ablation underwent intraarterial DEB administration (50-125 mg doxorubicin; mean, 60.2 mg+/-21.8). Follow-up period ranged 6-20 months (mean, 12 months+/-5). RESULTS No major complication occurred. No deterioration of liver function was observed. The volume of treatment-induced necrosis--as measured on imaging--increased from 48.1 cm3+/-35.7 after RF ablation to 75.5 cm3+/-52.4 after DEB administration, with an increase of 60.9%+/-39.0. The enhanced effect resulted in confirmed complete response (CR) of the target lesion in 12 (60%) of 20 patients. Incomplete response with persistence of <10% of initial tumour volume was observed in 6 (30%) of 20 patients, and local tumour progression in 2 (10%) of 20. CONCLUSIONS Intraarterial DEB administration substantially enhances the effect of RF ablation. DEB-enhanced RF ablation is safe and results in a high rate of CR in patients refractory to standard RF treatment.

Sirolimus-eluting versus bare-metal low-profile stent for renal artery treatment (GREAT trial): Angiographic follow-up after 6 months and clinical outcome up to 2 years

PURPOSE To evaluate the patency of sirolimus-eluting stents (SES) compared to bare-metal stents (BMS) in the treatment of atherosclerotic renal artery stenosis (RAS). METHODS Between November 2001 to June 2003, 105 consecutive symptomatic patients (53 men; mean age 65.7 years) with RAS were treated with either a bare-metal (n=52) or a drug-eluting (n=53) low-profile Palmaz-Genesis peripheral stent at 11 centers in a prospective nonrandomized trial. The primary endpoint was the angiographic result at 6 months measured with quantitative vessel analysis by an independent core laboratory. Secondary endpoints were technical and procedural success, clinical patency [no target lesion revascularization (TLR)], blood pressure and antihypertensive drug use, worsening of renal function, and no major adverse events at 1, 6, 12, and 24 months. RESULTS At 6 months, the overall in-stent diameter stenosis for BMS was 23.9%+/-22.9% versus 18.7%+/-15.6% for SES (p=0.39). The binary restenosis rate was 6.7% for SES versus 14.6% for the BMS (p=0.30). After 6 months and 1 year, TLR rate was 7.7% and 11.5%, respectively, in the BMS group versus 1.9% at both time points in the SES group (p=0.21). This rate remained stable up to the 2-year follow-up but did not reach significance due to the small sample. Even as early as 6 months, both types of stents significantly improved blood pressure and reduced antihypertensive medication compared to baseline (p<0.01). After 6 months, renal function worsened in 4.6% of the BMS patients and in 6.9% of the SES group. The rate of major adverse events was 23.7% for the BMS group and 26.8% for the SES at 2 years (p=0.80). CONCLUSION The angiographic outcome at 6 months did not show a significant difference between BMS and SES. Renal artery stenting with both stents significantly improved blood pressure. Future studies with a larger patient population and longer angiographic follow-up are warranted to determine if there is a significant benefit of drug-eluting stents in treating ostial renal artery stenosis.

Low-profile stent system for treatment of atherosclerotic renal artery stenosis : The GREAT trial

PURPOSE The Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent in Renal Artery Treatment (GREAT) Trial was designed to assess the safety and performance of a low-profile stent for the treatment of obstructive renal artery disease by looking at 6-month renal artery patency uniformly analyzed by a Core Lab. MATERIALS AND METHODS Fifty-two consecutive patients (mean age, 63.7 years) were successfully treated with the Palmaz Genesis Peripheral Stent (Cordis, Miami, FL) on the Slalom 0.018-inch Delivery System (Cordis Europe N.V., Oosteinde 8, NLO-9301 LJ Roden, The Netherlands) at 11 investigational centers. Patients with severe renal failure and > 8-mm renal artery were excluded. Primary endpoint was angiographic determination of in-stent percent diameter stenosis at 6 months. Fifty-one patients were treated with one stent, one patient was treated with two stents to cover the complete lesion. RESULTS Mean percentage diameter stenosis before renal angioplasty was 68.2% +/- 12.0%. No stent implantation failure, displacement, need for additional stent implantation, or procedural complication was observed. Six-month angiography was performed in 41 of 52 patients (79%) resulting in a mean in-stent percent diameter stenosis or Quantitative Vessel analysis (QVA) at 6 months of 23.9%. The in-stent binary (percent diameter stenosis > 50%) restenosis rate at 6 months was 14.3%. No fatal events occurred up to 6 months after implantation. Major adverse events occurred in five patients: four patients (7.7%) required a revascularization and one patient (1.9%) experienced a cerebrovascular event, which regressed spontaneously. CONCLUSIONS The Palmaz Genesis stent (Cordis) provides good results for renal artery stent placement, with an in-stent binary restenosis rate (percent diameter stenosis > 50%) at 6 months of 14.3% as determined with angiography.

Transcatheter arterial embolization followed by percutaneous ethanol injection in the treatment of hepatocellular carcinoma

PurposeThe aim of this study was to evaluate the effectiveness of transcatheter arterial embolization (TAE) followed by percutaneous ethanol injection (PEI) in the treatment of large hepatocellular carcinoma (HCC) lesions.MethodsFifteen patients with HCC were treated by means of TAE followed by 6–16 ethanol injections. In 10 patients, the HCC was solitary (3–8 cm); 3 patients had 1, and 2 patients had 2 daughter nodules (3 cm or smaller) in addition. In 12 of 15 main tumors and in 4 of 7 daughter nodules, a tumor capsule was observed by computed tomography or magnetic resonance imaging.ResultsCombined treatment with TAE and PEI resulted in complete necrosis of 12 of 15 main tumors and 7 of 7 daughter nodules on biopsy. Treatment failure (incomplete necrosis) occurred in 3 unencapsulated main tumors. The 1-year survival rate in 10 patients was 100%.ConclusionThe combination of TAE and PEI proved to be an effective treatment for large HCC, including those with 1–2 small daughter nodules. The presence of a tumor capsule significantly correlates (p < 0.05) with a favorable outcome of treatment.

The Erasme Study: A Multicenter Study on the Safety and Technical Results of the Palmaz Stent Used for the Treatment of Atherosclerotic Ostial Renal Artery Stenosis

AbstractPurpose: To assess, in a multicenter setting, safety, technical results, and restenosis rate of the Palmaz stent for treatment of atherosclerotic ostial renal artery stenosis. Methods: Ten centers enrolled 106 patients (120 treated renal artery stenoses) in the study. Patient selection was based on unsuccessful percutaneous transluminal renal angioplasty (residual stenosis ≥ 20%) performed for treatment of ostial stenosis ≥ 50%, in patients with hypertension and/or impaired renal function. Safety was assessed by means of the complication rate, and technical results by the number of successful stent placements and occurrence of restenosis (>50%) at intraarterial angiographic follow-up. Results: Stent placement was successful (n=112) or partially successful (n=5) in 117 (98%) arteries. Complications occurred in 19 procedures; seven were of serious clinical significance. Angiographic follow-up was performed in 89 of 117 (76%) cases, at a mean of 8 months (range 2.5–18 months). Fifteen stents (16.9%) showed restenosis (at a mean of 8.5 months), of which 10 were successfully redilated. Conclusion: Renal artery stenting has a high technical success rate, a complication rate comparable to percutaneous transluminal renal angioplasty, and a low rate of restenosis at 8 months angiographic follow-up.

Endovascular Repair of Abdominal Aortic Aneurysms: Analysis of Aneurysm Volumetric Changes at Mid-Term Follow-Up

PurposeTo evaluate the volumetric changes in abdominal aortic aneurysms (AAA) after endovascular AAA repair (EVAR) in 24 months of follow-up.MethodsWe evaluated the volume modifications in 63 consecutive patients after EVAR. All patients underwent strict duplex ultrasound and computed tomography angiography (CTA) follow-up; when complications were suspected, digital subtraction angiography was also performed. CTA datasets at 1, 6, 12, and 24 months were post-processed through semiautomatic segmentation, to isolate the aneurysmal sac and calculate its volume. Maximum transverse diameters (Dmax) were also obtained in the true axial plane, Presence and type of endoleak (EL) were recorded. A statistical analysis was performed to assess the degree of volume change, correlation with diameter modifications, and significance of the volume increase with respect to ELs.ResultsMean reconstruction time was 7 min. Mean volume reduction rates were 6.5%, 8%, and 9.6% at 6, 12, and 24 months follow-up, respectively. Mean Dmax reduction rates were 4.2%, 6.7%, and 12%; correlation with volumes was poor (r = 0.73–0.81). ELs were found in 19 patients and were more frequent (p = 0.04) in patients with higher preprocedural Dmax, The accuracies of volume changes in predicting ELs ranged between 74.6% and 84.1% and were higher than those of Dmax modifications. The strongest independent predictor of EL was a volume change at 6 months ≤0.3% (p = 0.005), although 6 of 19 (32%) patients with EL showed no significant AAA enlargement, whereas in 6 of 44 (14%) patients without EL the aneurysm enlarged.ConclusionThe lack of volume decrease in the aneurysm of at least 0.3% at 6 months follow-up indicates the need for closer surveillance, and has a higher predictive accuracy for an endoleak than Dmax.

Predictive Factors of In-Stent Restenosis in Renal Artery Stenting: A Retrospective Analysis

PurposeTo retrospectively evaluate the role of clinical and procedural factors in predicting in-stent restenosis in patients with renovascular disease treated by renal artery stenting.MethodsFrom 1995 to 2002, 147 patients underwent renal artery stenting for the treatment of significant ostial atherosclerotic stenosis. Patients underwent strict clinical and color-coded duplex ultrasound follow-up. Ninety-nine patients (111 stents), with over 6 months of continuous follow-up (mean 22±12 months, range 6–60 months), were selected and classified according to the presence (group A, 30 patients, 32 lesions) or absence (group B, 69 patients, 79 lesions) of significant in-stent restenosis. A statistical analysis was performed to identify possible preprocedural and procedural predictors of restenosis considering the following data: sex, age, smoking habit, diabetes mellitus, hypertension, serum creatinine, cholesterol and triglyceride levels, renal artery stenosis grade, and stent type, length and diameter.ResultsComparing group A and B patients (χ2 test), a statistically significant relation was demonstrated between stent diameter and length and restenosis: the risk of in-stent restenosis decreased when the stent was ≥6 mm in diameter and between 15 and 20 mm in length. This finding was confirmed by multiple logistic regression analysis. Stent diameter and length were proved to be significantly related to in-stent restenosis also when evaluating only patients treated by Palmaz stent (71 stents).ConclusionAlthough it is based on a retrospective analysis, the present study confirms the importance of correct stent selection in increasing long-term patency, using stents of at least 6 mm in diameter and with a length of approximately 15–20 mm.

Ultrasonographic Surveillance with Selective CTA after Endovascular Repair of Abdominal Aortic Aneurysm

Purpose: To evaluate the agreement between color-coded duplex ultrasound (US) and computed tomographic angiography (CTA) in monitoring aneurysm diameter and detecting endoleaks after endovascular aneurysm repair (EVAR). Methods: From November 1998 to January 2007, 196 patients (191 men; mean age 72.4 years, range 52–88) underwent EVAR and were followed by CTA and US over a mean 3.9±2.4 years (range 0––8.9, median 3.4). Annual paired CTA and US examinations were reviewed to assess agreement in measuring maximum aneurysm transverse diameter and to evaluate diagnostic accuracy of US in detecting endoleak. Results: The 5-year cumulative endoleak incidence was 43.8% (72 patients). At first diagnosis, US detected 55/72 (76.4%) endoleaks; of the remaining 17, only 3 (4.3%) were clinically significant in terms of aneurysm enlargement. Pairing 709 annual CTA and US examinations from 184 patients showed a high agreement (k=0.96) between examinations in measuring maximum transverse diameter, with a mean difference between US and CTA of −2.5 mm. Conclusion: After the first year of follow-up, EVAR surveillance costs can be reduced by performing annual US examinations only. Keeping in mind that US underestimates diameter measurements, CTA can be reserved for patients with increasing or persistently stable aneurysm diameters.

Cavoportal hemitransposition: patient selection criteria and outcome.

A SUCCESSFUL liver transplantation needs an adequate portal inflow. In cases of grade 4 portal vein (PV) thrombosis, ie, complete thrombosis of the PV, and the proximal and distal superior mesenteric veins, salvage procedures have been described to restore portal inflow: anastomosis of the donor PV with a suitable recipient PV tributary, arterialization of the donor PV to increase flow through the portal system, and multivisceral transplantation. Since the report of Tzakis et al, proposing cavoportal hemitransposition (CPHT) as a possible means of overcoming the problem of extensive PV thrombosis, individual case studies of CPHT have been published. The common complications after CPHT are severe ascites, renal insufficiency, and variceal bleeding. We here report the patient selection criteria and outcomes of the first eight transplantations performed using this technique at our Centre between July 2000 and February 2002.

Renal Artery Stenting in Patients with a Solitary Functioning Kidney

AbstractPurpose: To retrospectively evaluate the results of renal artery stenting in patients with renovascular disease and a solitary functioning kidney. Methods: Palmaz stents were placed in 16 patients with a solitary functioning kidney, renal artery stenosis, hypertension and renal failure. Stenoses were evaluated with color Doppler ultrasound, MR angiography and digital subtraction angiography (DSA). Indications for stenting were: recoil after percutaneous transluminal renal angioplasty (PTRA) (63%), arterial dissection after PTRA (13%) and primary stenting (25%). Immediate results were evaluated by DSA. On follow-up (6-36 months), patients underwent periodical evaluation of clinical conditions (blood pressure and serum creatinine level) and stent patency, by means of color Doppler ultrasound. Results: Stent placement was successful in all patients (100%). Cumulative primary patency rate was: 100% at 1 day, 93.75% at 6 months, 81.25% at 12 months and 75% at 24 months. A significant reduction in diastolic blood pressure occurred (mean ± SD 104 ± 6 vs 92 ± 3; p < 0.05); renal function improved or stabilized in over 80% of patients. However, there was no significant difference in the creatinine values before and after treatment (mean ± SD 200 ± 142 mmol/l vs 197 ± 182 mmol/l; p > 0.05). Conclusion: Renal artery stenting, both after PTRA and as primary stenting, represents a safe procedure, able to preserve renal function in patients with a solitary functioning kidney.